The Scope Fluidics Group, which operates in the life science sector and develops innovative technologies for the medical diagnostics and healthcare markets, has decided to begin efforts to obtain CE-IVDR certification for the BACTEROMIC system with a broad panel of antibiotics for Gram-negative bacteria and a testing time of 6 hours (UNI FAST Pro GN Panel).
Under this decision, Bacteromic will begin efforts to apply for IVDR certification for the system with the UNI FAST Pro GN panel, which enables assessment of antibiotic susceptibility in Gram-negative bacteria, before R&D work on the UNI FAST Pro panel is completed. The UNI FAST Pro panel will be dedicated to both Gram-negative and Gram-positive bacteria. Once that work is completed, the Company plans to apply for certification of the system with the UNI FAST Pro panel.
In the Management Board’s assessment, obtaining the IVDR certificate for the UNI FAST Pro GN panel before the IVDR certificate for the UNI FAST Pro panel will allow the range of BACTEROMIC panels available for sale to be expanded more quickly.
“The decision to begin efforts toward IVDR certification for the UNI FAST Pro GN panel is a very important step in the development of BACTEROMIC, the result of the fantastic work of our team, and an opportunity to expand the portfolio of BACTEROMIC system panels more quickly. We plan to submit the documentation to the notified body around the end of 2026 and the beginning of 2027. The panel under development is intended to combine a broad range of antibiotics, quantitative and qualitative assessment of antibiotic susceptibility, and a testing time of up to 6 hours. In our assessment, this combination of features is unique on the global market and meets the needs of microbiology laboratories very well. We anticipate that, once the required certification is obtained, the panel will be able to go on sale as early as 2027,” says Piotr Garstecki, CEO of Scope Fluidics.
The decision to apply for the IVDR certificate for this panel, which had not been planned earlier, was made on the recommendation of the Bacteromic team. In the course of R&D work on the BACTEROMIC system, the team identified an opportunity to prepare a comprehensive panel dedicated to Gram-negative bacteria for certification sooner. After analyzing the documentation under preparation, the Management Board concluded that beginning the process of obtaining the IVDR certificate for the UNI FAST Pro GN panel is justified from the standpoint of the development and commercialization of the BACTEROMIC system.
The UNI FAST Pro GN panel will be submitted with 34 antibiotics and the corresponding 54 antibiotic-bacterium combinations, as well as one resistance mechanism, ESBL. At the same time, the Company notes that the final number of antibiotics and drug-bug combinations will depend on the assessment of the notified body.
The Company maintains its existing plans for the UNI FAST Pro panel, that is, a panel enabling assessment of antibiotic susceptibility in both Gram-negative and Gram-positive bacteria within 6–8 hours. Bacteromic is continuing R&D work on the UNI FAST Pro panel and maintains its plan to apply for the IVDR certificate for this panel once the ongoing R&D work is completed.
As a reminder, in May 2026 Bacteromic obtained the CE-IVDR certificate for the BACTEROMIC system with the UNI FAST panel, which enables assessment of antibiotic susceptibility in Gram-negative and Gram-positive bacteria for a total of 24 antibiotics and the corresponding 48 antibiotic-bacterium combinations.
